绝经后激素受体阳性乳腺癌新辅助内分泌治疗对比新辅助化疗的非劣性研究

A non-inferiority trial on the effects of neoadjuvant endocrine therapy and neoadjuvant chemotherapy in postmenopausal hormone receptor positive breast cancer

目的:研究绝经后激素受体阳性乳腺癌新辅助内分泌治疗的有效率及安全性。方法:采用前瞻性非随机临床对照研究,将116例绝经后ER或PR≥50%、Her-2阴性的T2~3N0M0乳腺癌患者,非随机分入新辅助内分泌治疗组或新辅助化疗组,观察两组影像学、病理学有效率及用药安全性。结果:内分泌组客观有效率和临床获益率分别为81.43%,97.14%,化疗组为80.44%和98.12%,两组差异无统计学意义(P>0.05);内分泌组的超声完全缓解(ultrasound complete response,uCR)和病理完全缓解(pathological complete response,pCR)率(15.72%,10.00%)高于化疗组(10.87%,6.52%),差异有统计学意义(P<0.05);内分泌组不良反应发生率为11.43%,主要表现为较轻的颜面潮红及骨关节痛,而化疗组不良反应发生率为100%,且表现为较重的骨髓抑制及胃肠道反应,差异具有统计学意义(P<0.05)。结论:新辅助内分泌治疗与新辅助化疗对绝经后腋窝淋巴结阴性lumial型乳腺癌的总体临床疗效无差异,但前者的uCR/pCR率高于后者,有显著性差异,且不良反应很少,是一种安全、有效、耐受性良好的治疗方案。

Objective： To study the efficacy and safety of neoadjuvant endocrine therapy for postmenopausal hormone receptor positive breast cancer. Methods： A prospective non-randomized controlled clinical study, 116 cases of postmenopausal ER/PR≥50%, Her-2 negative T2–3N0M0 breast cancer patients, according to the freedom of choosing to enter the neoadjuvant endocrine therapy group or neoadjuvant chemotherapy group, the imaging and pathology of efficiency and safety was observed. Results： The objective response rate and clinical benefit rate were 81.43%, 97.14% in endocrine group, 80.44% and 98.12% of the chemotherapy group, with no significant difference between two groups（P〉0.05）; ultrasound complete response（uCR） and pathological complete response（pCR） rate（15.72%, 10.00%） in endocrine group was significant higher than the chemotherapy group（10.87%, 6.52%）, the difference was statistical（P〈0.05）; adverse reaction rate was 11.43% in endocrine group. The side effects were mild facial flushing and bone and joint pain, and in the chemotherapy group adverse reaction rate was 100%, and the performance of myelosuppression and gastrointestinal reactions were heavier, the difference has statistical significance（P〈0.05）. Conclusion： There is no difference in the overall clinical efficacy of neoadjuvant endocrine therapy and neoadjuvant chemotherapy on axillary lymph node negative Luminal breast cancer after menopause, but uCR/pCR was significantly higher than that of the latter, there are significant differences, and the side effect is tolerate, so neoadjuvant endocrine therapy is a safe and effective treatment.